Senior Director, Epidemiology

Accountabilities

• Strategic Leadership & Execution
• Develop and implement comprehensive epidemiology strategic plans aligned with corporate objectives across assigned therapeutic areas
• Advise the planning, prioritization, and execution of epidemiology deliverables including systematic literature reviews, real world data analyses, and observational studies/disease registries
• Optimize resource allocation and operational efficiency, ensuring deliverables meet quality, budget, and timeline requirements while incorporating innovative methodologies
• Collaborate with the department head on department-level strategic planning, including workforce planning, external resource evaluation, and real world data source assessment
• Navigate organizational ambiguities and policy complexities to ensure successful execution of critical initiatives
• Identify process gaps and lead the development and maintenance of Standard Operating Procedures and Process Guides
• Cross-Functional Collaboration
• Serve as the epidemiology lead on cross-functional therapeutic area teams, partnering with Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Commercial/Marketing, and HEOR
• Engage proactively with senior and executive leadership to integrate epidemiologic evidence into strategic decision-making throughout the product lifecycle
• Break down functional silos through influence, conflict resolution, and negotiation to achieve shared objectives
• Represent the department in high-level corporate meetings and critical initiatives
• Lead or contribute to R&D and corporate process improvement initiatives, finding opportunities to enhance efficiency and impact
• Absorb diverse team member needs, translating sophisticated epidemiologic concepts for varied audiences
• Provide executive-level presentations and recommendations that shape business strategy
• Technical Excellence & Innovation
• Serve as a recognized technical authority in epidemiologic methods, including observational study design, causal inference, safety signal quantification, and disease epidemiology
• Apply sophisticated analytical approaches using SAS, R, Python, or other statistical software to extract meaningful insights from sophisticated real world data sources
• Ensure all epidemiology deliverables reflect current standard processes and methodological advancements in pharmacoepidemiology
• Provide experienced technical guidance and scientific rigor across systematic literature reviews, database studies, and registry analyses
• Contribute epidemiologic expertise to study protocols, case report forms (CRFs), clinical conference materials, and regulatory documents
• Author and review scientific manuscripts, abstracts, and presentations based on observational study data, maintaining high publication standards
• Work with authors, referees, and in-house reviewers to ensure scientific quality and accuracy
• Stay current with emerging methodologies and data sources, recommending innovations that advance departmental capabilities
• Leadership & People Development
• Provide direct line management and leadership for Epidemiologists within assigned therapeutic areas, fostering a culture of scientific excellence and collaboration
• Mentor team members in epidemiologic methods, critical thinking, and professional development, supporting their growth as technical authorities and leaders
• Actively teach and mentor colleagues both within and outside the department, contributing to organizational capability building
• Lead vendor and contractor relationships, ensuring external partners deliver high-quality work aligned with strategic objectives
• Champion professional development for self and direct reports, creating opportunities for skill enhancement and career advancement
• Identify and develop future leaders within the department
• Conduct performance evaluations, provide constructive feedback, and support career progression for team members
• Build a diverse, inclusive, high performing team environment that values different perspectives and approaches

External Influence & Thought Leadership

• Represent the company and Epidemiology Department in interactions with regulatory authorities, Scientific Advisory Boards, and other external partners
• Influence industry standards and guidelines through active leadership in professional societies, industry associations, and regulatory working groups
• Build the company's reputation as a leader in rare disease epidemiology through publications, presentations, and scientific discourse
• Leverage deep expertise in rare disease epidemiology to advance understanding of disease burden, natural history, and treatment outcomes
• Establish and maintain relationships with key opinion leaders and external research collaborators
• Contribute to the broader scientific community through peer review, conference participation, and collaborative research initiatives
• Serve as a spokesperson for the organization at scientific conferences and industry events

Required Skills and Education

• PhD / DSc / DrPH in Epidemiology with minimum 12 years post-graduation experience, or MPH/MSc in Epidemiology with minimum 15 years post-graduation experience
• Minimum 6 years of direct line management experience of multiple reports
• Demonstrated expertise in epidemiologic methods, observational study design, causal inference, and real world data analysis
• Proficiency with SAS, R, Python, or other statistical software packages
• Thorough and current knowledge of pharmacoepidemiology methods and applications
• Strong understanding of safety signal quantification and risk-benefit assessment
• Consistent record of publications in peer-reviewed journals
• Exceptional oral and written communication skills with ability to present sophisticated information to diverse audiences
• Strong attention to detail, scientific rigor, and commitment to quality
• Experience working optimally in cross-functional, matrixed environments
• Demonstrated ability to influence senior partners and drive consensus
• High degree of self-motivation, organization, and adaptability
• Comfort working in a fast-moving environment with evolving priorities

Desired Skills

• Deep expertise and demonstrated experience in rare disease epidemiology
• Knowledge of drug development processes and regulatory requirements across the product lifecycle
• Experience collaborating with regulatory authorities (FDA, EMA, etc.)
• Active leadership roles in professional societies (ISPE, ISPOR, etc.) or industry associations
• Track record of thought leadership through publications, presentations, and external engagement
• Experience with multiple real world data sources including claims databases, electronic health records, and patient registries
• Experience in registry development, implementation, and analysis